- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01694121
Evaluating a Structural and Behavioral HIV Risk Reduction Program for Black Men (MENCount)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
District of Columbia
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Washington, District of Columbia, Forenede Stater, 20052
- George Washington University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria: Black men aged 18 and older, reporting heterosexual risk for HIV [unprotected sex with a woman and 2+ female sex partners in the past 6 months] and either current unemployment or homeless in the past 6 months.
Exclusion Criteria: planned to leave Washington D.C., Maryland, or Virginia in the next 6 months, were cognitively impaired (based on Folstein Mini-Mental Exam at recruitment or baseline testing), and/or had self-reported health status that prohibited them from participating in the program
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: MEN Count
3 session HIV intervention including a) HIV risk reduction, inclusive of gender equity and healthy relationship counseling and b) case management support for stable employment and housing.
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The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period.
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Aktiv komparator: Comparison
An attention comparison program similar to the MEN Count intervention in structure (3 one-on-one sessions delivered over 60-90 days) but focused on stress reduction and healthy lifestyle.
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general health intervention for men, not inclusive of HIV or relationship health
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up
Tidsramme: 12 month follow-up
|
Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement.
Very low sexual risk was defined as having one partner and consistent condom use.
Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use.
Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex.
High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex.
Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each.
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12 month follow-up
|
Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up
Tidsramme: 6 month follow-up
|
Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement.
Very low sexual risk was defined as having one partner and consistent condom use.
Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use.
Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex.
High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex.
Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each.
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6 month follow-up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Non-viral STI - 12 Month Follow-up
Tidsramme: 12 month follow-up
|
HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time
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12 month follow-up
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Non-viral STI - 6 Month Follow-up
Tidsramme: 6 month follow-up
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HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time
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6 month follow-up
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Anita Raj, PhD, UCSD
- Ledende efterforsker: Lisa Bowleg, PhD, George Washington University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- R01MH096657 (U.S. NIH-bevilling/kontrakt)
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